A Study to Evaluate the Diagnostic Efficacy of 68Ga- MY6349 PET/CT in Patients With Tumours

Air Force Military Medical University of People's Liberation Army

Status: Enrolling

Conditions: Tumour of Epithelial Origin; 68Ga-MY6349

Treatments: Diagnostic Test: 68Ga-MY6349 PET/CT Scan

Study type: Interventional

Funder types: Other

Identifiers

NCT06770478

KY20242273-C-1

Details and patient eligibility

About

This is a study using an autocontrol approach, enrolling 40 patients with tumours of epithelial origin, who underwent 68Ga- MY6349 and 68Ga-PSMA/18F-FDG PET/CT imaging of patients with tumours of epithelial origin to compare the ability to diagnose, stage and monitor recurrence of tumours of epithelial origin using the pathological findings as the gold standard.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years; Patients with pathologically confirmed tumour and proposed surgical resection/exploration (including primary or recurrent metastatic tumour); Expected survival > 3 months, as judged by the doctor; Voluntarily sign the informed consent form; willing and able to follow the study protocol

Exclusion criteria

• Persons with a known history of hypersensitivity to 68Ga-MY6349 and 68Ga-PSMA or 18F-FDG and their excipients; Those who cannot tolerate intravenous drug delivery methods (e.g., history of needle and blood sickness); Patients who have received anti-tumour therapy before the examination or neoadjuvant chemotherapy/targeted therapy for tumour reduction after the examination and up to the preoperative period; Pregnant and lactating women; Practitioners who need to be exposed to radioactive conditions for a long time; Serious diseases of heart, kidney, lung, vascular, neurological and psychiatric systems, immunodeficiency diseases and hepatitis/cirrhosis; Have participated in other interventional clinical trials within 1 month prior to screening; Patients undergoing chemotherapy, immunotherapy or molecular targeted therapy; Presence of other conditions that, in the opinion of the investigator, make participation in this study unsuitable.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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40 participants in 1 patient group

before-after study in the same patient

Experimental group

Description:

This study is planned to include about 40 patients with tumours of epithelial origin who are proposed for benign-malignant diagnosis or initial staging or recurrence monitoring. Screened subjects will undergo 68Ga-MY6349 and 68Ga-PSMA/18F-FDG PET/CT sequentially within 2 weeks, and pathological results will be obtained within 30 days after drug administration. Histopathological findings and imaging results will be used as the gold standard for final diagnosis. Translated with DeepL.com (free version)

Treatment:

Diagnostic Test: 68Ga-MY6349 PET/CT Scan